Public Release: 

New study may widen options in breast cancer treatment

Cooney Waters Group, Inc.

Research results from AACR 91st annual meeting

SAN FRANCISCO, April 3, 2000 -- New data presented at the 91st Annual Meeting of the American Association for Cancer Research (AACR) strengthen the evidence for the use of two biomarkers to predict relapse, which may help certain women avoid the rigors of adjuvant chemotherapy.

In breast cancer, adjuvant chemotherapy -- treatment with anticancer drugs after the tumor has been removed -- is standard for women whose lymph nodes test positive for the disease. When nodes show no sign of cancer, a decision to conduct post-surgical treatment is less clear. Researchers in a prospective, multicenter German trial called Chemo N0 investigated the relapse-predicting value of a protein called uPA (urokinase-type plasminogen activator) and its type-1 inhibitor, PAI-1. Both substances have been linked to poor prognosis in women with node-negative breast cancer.

"We have found that these two markers are unique among prognostic factors in breast cancer in that they have consistently demonstrated a correlation with both duration of disease-free survival and overall survival," said Anita Prechtl, M.D., assistant professor of Obstetrics and Gynecology at Munich's Technical University. On the basis of uPA and PAI-1 measurements from our long-term data, more than half of all node-negative breast cancer patients can be considered to have low risk of relapse and may be spared the burden of chemotherapy."

Tumors from 556 breast cancer patients with negative nodal status were evaluated for uPA and PAI-1 levels by ELISA (enzyme-linked immunosorbent assay) supplied by American Diagnostica Inc. of Greenwich, CT. Of the total, 241 women with low levels of both uPA and PAI-1 received no further treatment. Through a combination of random assignment and patient request, 315 women with high levels of uPA, PAI-1, or both, participated in one of two study arms: 114 women received adjuvant chemotherapy with the commonly used combination of CMF (cyclophosphamide, methotrexate, 5-fluorouracil; 114 women), and 201 women were observed only.

After a median follow-up of 32 months, investigators found that risk of relapse was less than 10 percent in the node-negative women with low uPA and PAI-1 levels. They also found that CMF reduced risk of recurrence by 43 percent in the high-risk group assigned to adjuvant chemotherapy.

The German researchers consider their findings strong enough to recommend routine uPA and PAI-1 testing of primary tumors from node-negative breast cancer patients, but will continue to monitor patients in the Chemo N0 trial.

The same research group is participating in a prospective international study that began last year. The new clinical trial, supported by the BIOMED-2 health program of the European Commission and again using kits provided by American Diagnostica, will assess the performance of uPA and PAI-1, and the HER-2/neu oncogene, which may also be associated with poor five-year prognosis in early-stage breast cancer, in predicting relapse risks for node-negative breast cancer patients.

More than 10,000 scientists from around the world will gather at this year's AACR meeting to exchange information on the most up-to-date scientific developments. Other groundbreaking research to be highlighted includes new diagnostics for early prostate cancer detection and early data on a topical compound that may prevent chemotherapy-induced hair loss.

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Founded in 1907, the American Association for Cancer Research (AACR) is a professional organization of more than 15,000 laboratory and clinical scientists engaged in cancer research in the United States, Canada, and more than 60 other countries. Working to prevent and cure cancer, AACR's principal activities include scientific communications; education and training of young scientists; public education; scientific meetings for the presentation and discussion of discoveries in the cancer field; international programs; and the publication of four major peer-reviewed scientific journals (Cancer Research, Clinical Cancer Research, Cell Growth & Differentiation, and Cancer Epidemiology, Biomarkers & Prevention).

"Risk-Adapted Adjuvant Chemotherapy in Node-Negative Breast Cancer Patients Guided By Prognostic Factors UPA and PAI-1: First Interim-Analysis of a Randomized Trial" (Abstract #2101) Anita Prechtl, Thomssen Christoph, Meisner Christoph, Michael Untch, Werner Weikel, Gabriele Wieland, Bjoern W. Lisboa, Peter Hantschmann, Thomas Beck, Tanja Cufer, Peter Scheler, and Volker Moebus Poster Session: Monday, April 3, 11:30 a.m. - 2:30 p.m., Exhibit Hall B-C, Section 2

News Briefing: Monday, April 3, 10:00 a.m. - 10:45 a.m. (PDT)

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